AsthmaEXPRESANCT00721097
Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics
An observational study of Asthma and Chronic Inflammatory Diseases, run by Nantes University Hospital at 1 site in France.
Trial summary
Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma, Chronic Inflammatory Diseases
- What is being tested?
- spirometry, and blood taken
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2008to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe asthma
Who may be able to join
- Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure
- Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy
Who cannot join
- Pregnant or nursing women
- Patients with other chronic inflammatory lung disease
- Current smoker or a smoking history of 10 pack years or more
Trial locations and contacts
1 site in 1 country.
About this study
Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.
- Conditions
- Asthma, Chronic Inflammatory Diseases
- Being tested
- spirometry, and blood taken
- Keywords
- Severe asthma, exacerbation, predictive factors, Severe
- Medical subject headings
- Asthma, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometry, and blood takenOther
each month during one year
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of predictive factors for exacerbation outcome in severe asthmatics.
Secondary outcomes (1)
Rate of predictive factors identified in the study, in order to prevent exacerbations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Number of included patients is sufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Antoine MAGNAN, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721097
- Sponsor's protocol ID
- BRD 07/6-X
- Acronym
- EXPRESA
- Status last verified
- Sep 2013
- First submitted
- 7 Jul 2008
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics
- ClinicalTrials.gov ID
- NCT00721097
- Acronym / sponsor ID
- EXPRESA / BRD 07/6-X
- Conditions
- Asthma, Chronic Inflammatory Diseases
- Keywords
- Severe asthma, exacerbation, predictive factors, Severe
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Number of included patients is sufficient.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe asthma
Key inclusion criteria (2 listed)
- Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure
- Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy
Key exclusion criteria (3 listed)
- Pregnant or nursing women
- Patients with other chronic inflammatory lung disease
- Current smoker or a smoking history of 10 pack years or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometry, and blood takeneach month during one year | Other | – |
Primary outcome
Number of predictive factors for exacerbation outcome in severe asthmatics.
1 secondary outcome
Rate of predictive factors identified in the study, in order to prevent exacerbations.
Results and safety
The study was stopped early (reason given: Number of included patients is sufficient.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine MAGNAN, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Inflammatory Diseases, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Number of included patients is sufficient.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of predictive factors for exacerbation outcome in severe asthmatics.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.